Driven Sports Inc. has some new supplements it would like to start selling, but after its product, CRAZE, was found to contain an unapproved meth-like ingredient, the U.S. Food and Drug Administration (FDA) says it will need some information first. In a warning letter to the company dated April 4, the FDA outlined next steps for the company.
CRAZE, which was marketed as a sports supplement, contains “Dendrobex”, which is listed on the product label as an ingredient and N,α-diethylphenylethylamine, the meth-like ingredient, which is not. Neither chemical is approved for use in dietary supplements, so the presence of either one renders product adulterated, according to the FDA.
The company has both disputed claims that CRAZE contains N,α-diethylphenylethylamine and cited claims that CRAZE contains N,α-diethylphenylethylamine as the reason it has stopped distributing the product. Whether N,α-diethylphenylethylamine is in CRAZE or not, the use of Dendrobex alone is enough to adulterate the product and prohibit the lawful sale of CRAZE.
What’s more, says the agency, the company’s claim that Dendrobex is a Dendrobium Extract that contains phenethylamine-type alkaloids (PEAs) – such as B-Phenylethylamine, N,N-Dimethyl-B-Phenylethylamine, and N,N-Diethyl-B-Phenylethylamine, is inaccurate. Based on peer-reviewed scientific literature, those chemicals are not present in the Dendrobium species, the agency said, and requested an explanation of why PEAs are present in CRAZE.
Driven Sports Inc. never issued a recall for CRAZE and was supposed to have destroyed its remaining stockpile of the product. The FDA would like the company to provide documentation of the destruction of CRAZE and meet with the agency to discuss its ppans for future products. The company has 15 days to reply.
